Pharmacovigilance & Safety Management
This service ensures comprehensive safety oversight in paediatric clinical studies. It covers the active management, assessment, and reporting of serious adverse events (SAEs) and suspected unexpected severe adverse reactions (SUSARs/SADEs) to regulatory authorities and Ethics Committees within required timelines. Activities include preparing Development Safety Update Reports (DSURs) and other periodic safety reports, as well as reconciling safety data with clinical data. The service also supports interactions with Data Safety Monitoring Boards (DSMBs) and ensures compliance with international pharmacovigilance standards, safeguarding patient protection across the entire study lifecycle.
